Trial to Evaluate Topical C-82 in a Psoriasis Plaque Test

Prism Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Psoriasis

Treatments: Drug: Daivonex cream; Drug: Diprosis gel; Drug: C-82 Topical Gel, 1%; Drug: C-82 Topical Gel, Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02432027

PRI-C-82T-2101

Details and patient eligibility

About

Evaluate the effects of topical C-82 in a psoriasis plaque test.

Full description

The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.

Enrollment: 14 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild to moderate chronic stable plaque type psoriasis
• plaques thickness of at least 200 µm
• lesion(s) on the trunk or extremities (excluding palms/soles)
• skin must be without disease findings

Exclusion criteria

• other skin disease
• psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
• treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial
• treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial
• treatment with any biologics within 3 months preceding and during the trial
• known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. Carbomere 940, propylene glycol)
• drug or alcohol abuse
• symptoms of a clinically significant illness within 4 preceding and during the trial
• participation another clinical trial within 4 weeks of this clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

14 participants in 4 patient groups, including a placebo group

IMP 1

Experimental group

Description:

C-82 Topical Gel, 1%

Treatment:

Drug: C-82 Topical Gel, 1%

IMP 2

Placebo Comparator group

Description:

C-82 Topical Gel, placebo

Treatment:

Drug: C-82 Topical Gel, Placebo

IMP 3

Active Comparator group

Description:

Daivonex cream

Treatment:

Drug: Daivonex cream

IMP 4

Active Comparator group

Description:

Diprosis gel

Treatment:

Drug: Diprosis gel